Filter integrity testing device and testing process

Abstract

The invention discloses a filter integrity testing device and a testing process. Relates to the technical field of medicine production degerming and filtering processes, and comprises a disposable degerming and filtering system, the disposable degerming and filtering system comprises a disposable degerming and filtering assembly, a sterile connector and a liquid storage bag, and the disposable degerming and filtering assembly is sequentially connected with the sterile connector and the liquid storage bag; the peristaltic pump is communicated with the disposable sterilizing and filtering system; the integrity detector is communicated with the disposable sterilizing and filtering system; and the wetting fluid container is communicated with the disposable sterilizing and filtering system. According to the invention, the integrity of the liquid main filter for directly filtering the liquid medicine in the disposable degerming and filtering system can be tested before use and after sterilization, and the influence on the reliability of the integrity test result of the liquid main filter after use caused by the interference of the liquid medicine on the liquid main filter in the filtering process is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of sterilization and filtration technology for pharmaceutical production, and more particularly to a filter integrity testing device and testing process. Background Art

[0002] As pharmaceuticals are closely linked to human health, they are subject to strict quality management regulations, especially for sterile drugs and biological products. Sterile drugs are subject to sterility testing in statutory drug standards, so their production must minimize the presence of microorganisms and various particulates. The special nature of biological products necessitates specialized controls during the production process and during the inspection of intermediate products, including sterility control. This creates an urgent need for the application of sterilizing filtration technology in the production of sterile drugs and biological products.

[0003] To ensure the quality of the final product, sterile pharmaceuticals and biological products require strict sterility control throughout their production processes, particularly with the application of pre-fill sterilization filtration technology. In existing production processes, most companies utilize some degree of open-containment handling during the preparation of pharmaceutical intermediates, which carries the risk of contamination. This, combined with the potential for contamination introduced from the front end of the production process, necessitates final sterilization filtration prior to filling to mitigate the risk of microbial contamination. Whether for terminally sterilized or non-terminally sterilized products, or even for biological products, final sterilization filtration prior to filling is essential to reduce microbial contamination. Due to various factors, most companies employ a post-fill sterilization filtration process to assess the filter integrity after sterilization to ensure compliance with the sterilization filtration process. However, this post-use integrity testing of sterilizing filters alone fails to detect any pre-use damage and risks potential clogging by product during use, failing to accurately reflect the filter's integrity prior to use.

[0004] Therefore, how to provide a filter integrity test device and test process that can overcome the impact of the existing sterilization filtration technology on the liquid main filter when filtering the Chinese medicine liquid in the pharmaceutical production process and can truly reflect the effectiveness of the sterilization filtration process is a problem that technicians in this field urgently need to solve. Summary of the Invention

[0005] In view of this, the present invention provides a filter integrity testing device and testing process, which aims to solve one of the problems in the above-mentioned background technology, overcome the impact of the traditional Chinese medicine liquid filtration in the existing pharmaceutical production process on the liquid main filter, and can truly reflect the sterilization filtration process.

[0006] In order to achieve the above object, on the one hand, the present invention adopts the following technical solutions:

[0007] A filter integrity testing device and testing process, comprising:

[0008] A disposable sterilizing filtration system, comprising a disposable sterilizing filter assembly, a sterile connector, and a liquid storage bag, wherein the disposable sterilizing filter assembly is sequentially connected to the sterile connector and the liquid storage bag;

[0009] a peristaltic pump, the peristaltic pump being in communication with the disposable sterilizing and filtering system;

[0010] an integrity detector, the integrity detector being in communication with the disposable sterilizing and filtration system;

[0011] A wetting fluid container is connected to the disposable sterilizing filtration system.

[0012] Furthermore, the disposable sterilizing filter assembly includes a liquid main filter, a first gas filter, a first liquid filter, a second gas filter and a second liquid filter, wherein:

[0013] The liquid inlet front end of the liquid main filter is connected to the sterile connector through a pressure-resistant braided tube, the liquid outlet rear end of the liquid main filter is connected to another sterile connector through a pressure-resistant braided tube, and the exhaust port near the liquid outlet end of the liquid main filter is connected to the liquid storage bag;

[0014] The first gas filter is connected to the pressure-resistant braided tube between the liquid inlet front end and the sterile connector of the liquid main filter through a pressure-resistant braided tube and a T-shaped connector;

[0015] The first liquid filter is connected to the pressure-resistant braided tube between the liquid inlet front end of the liquid main filter and the sterile connector through a pressure-resistant braided tube and a T-shaped connector, and the peristaltic pump is connected to the end of the first liquid filter away from the pressure-resistant braided tube;

[0016] The second gas filter is connected to the pressure-resistant braided tube between the liquid outlet rear end of the liquid main filter and the sterile connector through a pressure-resistant braided tube and a cross-shaped connector;

[0017] The second liquid filter is connected to the other end of the cross-shaped connector connected to the second gas filter, and the exhaust port of the second liquid filter is connected to the liquid storage bag.

[0018] Furthermore, one end of the first liquid filter away from the pressure-resistant braided tube is connected to the wetting fluid container via a silicone tube, and the silicone tube connecting the wetting fluid container and the first liquid filter is placed in the peristaltic pump;

[0019] The air outlet of the integrity detector is connected to the air inlet of the first gas filter, and the integrity detector is connected to compressed gas;

[0020] The wetting fluid container is connected to the liquid outlet end of the second liquid filter through a silicone pipe.

[0021] Furthermore, an upper point is provided on the pressure-resistant braided tube connected to the liquid main filter, the first gas filter, the first liquid filter, the second gas filter and the second liquid filter, and a PVPP flow regulating valve is provided at the upper point.

[0022] In another aspect, the present invention provides a filter integrity testing process, based on the filter integrity testing device described above, comprising the following steps:

[0023] Step 1: Perform a pre-use pressure leak test on the disposable sterile filtration system to confirm whether the disposable sterile filtration system is complete. Connect the disposable sterile filter assembly, sterile connector, and liquid storage bag. Clamp the pipes at the upper point of the disposable sterile filtration system with PVPP flow control valves. Open the PVPP flow control valve at the upper point of the pressure-resistant braided tube connected to the first gas filter.

[0024] Step 2: Turn on the compressed gas and integrity tester, set the test program, and start automatic operation. The integrity tester will record the test process and issue the test results;

[0025] Step 3: Perform a post-sterilization integrity test on the liquid main filter that has passed the leak test before use. If the leak test passes, open the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the first liquid filter and the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the second liquid filter, and simultaneously close the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the first gas filter;

[0026] Step 4: Turn on the peristaltic pump to allow the wetting fluid to circulate from the wetting fluid container through the silicone pipe, the first liquid filter, the pressure-resistant braided tube, the main liquid filter, the pressure-resistant braided tube, the second liquid filter, the silicone pipe, and back to the wetting fluid container;

[0027] Step 5: After the wetting process is completed, close the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the first liquid filter. At the same time, open the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the first gas filter. Set the test program on the integrity tester and start the automatic operation. The integrity tester records the test process and issues the test results.

[0028] Step 6: The disposable sterilization filtration system that has passed the integrity test before use and sterilization can be used for subsequent sterilization filtration of drug solutions.

[0029] As can be seen from the above technical solutions, compared with the prior art, the present invention provides a filter integrity testing device and testing process, which have the following advantages:

[0030] 1. The filter integrity test device provided by the present invention can perform a pre-use and post-sterilization integrity test on the liquid main filter that directly filters the liquid medicine in a disposable sterilizing filtration system. This can promptly determine whether the disposable sterilizing filtration system is intact and reliable, and prevent the liquid medicine itself from interfering with the liquid main filter during the filtration process, thereby affecting the reliability of the integrity test results of the liquid main filter after use.

[0031] 2. The use of the first gas filter and the first liquid filter in the disposable sterilizing filtration system provided by the present invention ensures the sterility of the test gas and the wetting fluid flowing through the main liquid filter, thereby avoiding interference with the integrity test of the main liquid filter before use and contamination of the liquid to be filtered;

[0032] 3. The configuration of the second gas filter and the second liquid filter in the disposable sterilizing filtration system provided by the present invention can ensure the sterility of the wetting fluid at the rear end of the main liquid filter and the emptying process after the main liquid filter passes the integrity test before use, thereby largely preventing the wetting fluid from diluting the subsequent filtered liquid and affecting product quality.

[0033] 4. The use of liquid storage bags in disposable sterilizing filtration systems ensures that the filter is isolated from the outside environment during the exhaust operation, avoiding gas exchange with the outside environment and contaminating the disposable sterilizing filtration system and subsequent liquid medicine;

[0034] 5. The sterile connectors at both ends of the disposable sterile filtration system ensure the sterility of the subsequent connection process, ensuring that the sterility of the connection can be guaranteed even when used in a lower clean environment level, greatly improving the convenience of operation;

[0035] 6. The filter integrity test device provided by the present invention has a simple structure and a simple testing process. Liquid main filters of different materials, models, and sizes can be replaced according to the properties of different liquids and the amount of liquid to be filtered, which greatly improves the versatility and operability of the process.

[0036] 7. The present invention relates to a process of performing a post-sterilization integrity test on a liquid main filter that directly filters liquid medicine in a disposable sterilizing filtration system before use, which does not destroy the sterility of the rear end of the liquid main filter, thereby better ensuring the sterility reliability of the subsequent liquid medicine filtration process. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0038] Figure 1 A schematic structural diagram of the filter integrity testing device provided by the present invention;

[0039] Figure 2 This is a schematic structural diagram of the disposable sterilizing filtration system provided by the present invention.

[0040] Among them: 1 is a disposable sterilization filtration system; 11 is a main liquid filter; 12 is a first gas filter; 13 is a first liquid filter; 14 is a second gas filter; 15 is a second liquid filter; 16 is a pressure-resistant braided tube; 17 is a T-type connector; 18 is a cross-type connector; 19 is a silicone tube; 2 is a sterile connector; 3 is a liquid storage bag; 4 is a peristaltic pump; 5 is an integrity tester; 6 is a container for wetting fluid; 7 is an upper site. DETAILED DESCRIPTION

[0041] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0042] See also Figure 1-2 The embodiment of the present invention discloses a filter integrity testing device and testing process, including:

[0043] A disposable sterilizing filtration system includes a disposable sterilizing filter assembly 1, a sterile connector 2, and a liquid storage bag 3. The disposable sterilizing filter assembly 1 is connected to the sterile connector 2 and the liquid storage bag 3 in sequence.

[0044] Peristaltic pump 4, which is connected to the disposable sterilization filtration system; the peristaltic pump 4 provides driving force for wetting the liquid main filter 11;

[0045] Integrity tester 5, which is connected to the disposable sterilizing filtration system; the integrity tester 5 performs integrity testing on the liquid main filter 11 and feeds back the test results;

[0046] The wetting fluid container 6 is connected to the disposable sterilizing filtration system; the wetting fluid is provided when the integrity test of the liquid main filter 11 in the disposable sterilizing filtration system is performed after sterilization before use.

[0047] In this embodiment, the disposable sterilizing filter assembly 1 includes a liquid main filter 11, a first gas filter 12, a first liquid filter 13, a second gas filter 14 and a second liquid filter 15, wherein:

[0048] The liquid inlet front end of the liquid main filter 11 is connected to the sterile connector 2 through a pressure-resistant braided tube 16, and the liquid outlet rear end of the liquid main filter 11 is connected to another sterile connector 2 through a pressure-resistant braided tube 16. The exhaust port near the liquid outlet end of the liquid main filter 11 is connected to the liquid storage bag 3; the liquid main filter 11 is used for filtering liquid medicine;

[0049] The first gas filter 12 is connected to the pressure-resistant braided tube 16 between the liquid inlet front end of the liquid main filter 11 and the sterile connector 2 through a pressure-resistant braided tube 16 and a T-shaped connector 17;

[0050] The first liquid filter 13 is connected to the pressure-resistant braided tube 16 between the liquid inlet front end of the liquid main filter 11 and the sterile connector 2 through a pressure-resistant braided tube 16 and a T-connector 17. The peristaltic pump 4 is connected to the end of the first liquid filter 13 away from the pressure-resistant braided tube 16.

[0051] The second gas filter 14 is connected to the pressure-resistant braided tube 16 between the liquid outlet rear end of the liquid main filter 11 and the sterile connector 2 through a pressure-resistant braided tube 16 and a cross-shaped connector 18;

[0052] The second liquid filter 15 is connected to the other end of the cross connector 18 connected to the second gas filter 14, and the exhaust port of the second liquid filter 15 is connected to the liquid storage bag 3;

[0053] In this embodiment, the end of the first liquid filter 13 away from the pressure-resistant braided tube 16 is connected to the wetting fluid container 6 via a silicone tube 19. The silicone tube 19 connecting the wetting fluid container 6 and the first liquid filter 13 is placed in the peristaltic pump 4.

[0054] The air outlet of the integrity detector 5 is connected to the air inlet of the first gas filter 12, and the integrity detector 5 is connected to compressed gas;

[0055] The wetting fluid container 6 is connected to the liquid outlet of the second liquid filter 15 via a silicone pipe 19;

[0056] In this embodiment, an upper point 7 is provided on the pressure-resistant braided tube 16 connected to the liquid main filter 11, the first gas filter 12, the first liquid filter 13, the second gas filter 14, and the second liquid filter 15, and a PVPP flow regulating valve is provided at the upper point 7;

[0057] In another aspect, the present invention provides a filter integrity testing process, based on the above-mentioned filter integrity testing device, comprising the following steps:

[0058] Step 1: Perform a pre-use pressure leak test on the disposable sterile filtration system to confirm whether the disposable sterile filtration system is complete. Connect the disposable sterile filter assembly 1, the sterile connector 2, and the liquid storage bag 3. Clamp the pipes at the upper position 7 of the disposable sterile filtration system with PVPP flow control valves. Open the PVPP flow control valve at the upper position 7 of the pressure-resistant braided tube connected to the first gas filter 12.

[0059] Step 2: Turn on the compressed gas and the integrity detector 5, set the test program, start automatic operation, and let the integrity detector 5 record the test process and issue the test results;

[0060] Step 3: Perform a post-sterilization integrity test on the liquid main filter 11 that has passed the leak test before use. If the leak test passes, open the PVPP flow control valve at position 7 on the pressure-resistant braided tube 16 connected to the first liquid filter 13 and the PVPP flow control valve at position 7 on the pressure-resistant braided tube 16 connected to the second liquid filter 15. At the same time, close the PVPP flow control valve at position 7 on the pressure-resistant braided tube 16 connected to the first gas filter 12.

[0061] Step 4: Turn on the peristaltic pump 4 to allow the wetting fluid to circulate from the wetting fluid container 6 through the silicone tube 19, the first liquid filter 13, the pressure-resistant braided tube 16, the main liquid filter 11, the pressure-resistant braided tube 16, the second liquid filter 15, and the silicone tube 19 back to the wetting fluid container 6;

[0062] Step 5: After the wetting process is completed, the PVPP flow control valve at position 7 on the pressure-resistant braided tube 16 connected to the first liquid filter 13 is closed. At the same time, the PVPP flow control valve at position 7 on the pressure-resistant braided tube 16 connected to the first gas filter 12 is opened. The test program is set on the integrity tester 5 and the test starts automatically. The integrity tester 5 records the test process and issues the test results.

[0063] Step 6: The disposable sterilization filtration system that has passed the integrity test before use and after sterilization can be used for subsequent sterilization filtration of drug solutions;

[0064] In addition, in this embodiment, the disposable sterilizing filter assemblies 1 are all configured as disposable capsule filters and have a fixed flow direction.

[0065] Example 1: A disposable sterilizing filtration system and filter integrity testing device for sterilizing and filtering the Sabin strain inactivated poliomyelitis vaccine semi-finished product (hereinafter referred to as sIPV semi-finished product) during the preparation process, capable of performing post-sterilization integrity testing before use:

[0066] The filter integrity testing device provided in this embodiment includes: a disposable sterilizing filtration system, a peristaltic pump 4, an integrity detector 5, and a wetting fluid container 6. In this embodiment, the wetting fluid container 6 is a 10L screw-top bottle with a silicone siphon head consisting of a long silicone tube, a short silicone tube, and a silicone air tube.

[0067] The disposable sterilization filtration system of this embodiment includes: a liquid main filter 11, a first gas filter 12, a first liquid filter 13, a second gas filter 14 and a second liquid filter 15, wherein: the liquid main filter 11 is a hydrophilic filter, model: KA2EKV, the filter element material is polyethersulfone; the first gas filter 12 is a hydrophobic filter, model: KA1V002PV1, the filter element material is polyvinylidene fluoride; the first liquid filter 13 is a hydrophilic filter, model: KA02EKVP8, the filter element material The second gas filter 14 is a hydrophobic filter, model: KA02V002P2, and the filter element material is polyvinylidene fluoride; the second liquid filter 15 is a hydrophilic filter, model: KA02EKVP2, and the filter element material is polyethersulfone, two sterile connectors 2, model: PSC1G10; two liquid storage bags 3, with capacities of 2L and 5L respectively, two T-connectors 17, a cross connector 18, multiple pressure-resistant braided tubes 16, multiple silicone tubes 19 and tube connection node fixing devices;

[0068] The liquid main filter 11 for filtering sIPV semi-finished products has a liquid inlet connected to a sterile connector 2 via a pressure-resistant braided tube 16. The liquid outlet of the main liquid filter 11 is connected to another sterile connector 2 via a pressure-resistant braided tube 16. The exhaust port near the liquid outlet of the main liquid filter 11 is connected to the liquid storage bag 3. The main liquid filter 11 is used for filtering liquid medicine.

[0069] The first gas filter 12 is connected to the pressure-resistant braided tube 16 between the liquid inlet front end of the liquid main filter 11 and the sterile connector 2 through a pressure-resistant braided tube 16 and a T-shaped connector 17;

[0070] The first liquid filter 13 is connected to the pressure-resistant braided tube 16 between the liquid inlet front end of the liquid main filter 11 and the sterile connector 2 through a pressure-resistant braided tube 16 and a T-connector 17. The peristaltic pump 4 is connected to the end of the first liquid filter 13 away from the pressure-resistant braided tube 16.

[0071] The second gas filter 14 is connected to the pressure-resistant braided tube 16 between the liquid outlet rear end of the liquid main filter 11 and the sterile connector 2 through a pressure-resistant braided tube 16 and a cross-shaped connector 18;

[0072] The second liquid filter 15 is connected to the other end of the cross connector 18 connected to the second gas filter 14, and the exhaust port of the second liquid filter 15 is connected to the liquid storage bag 3;

[0073] The peristaltic pump 4 of this embodiment provides a driving force for wetting the main liquid filter 11 when performing a pre-use and post-sterilization integrity test on the main liquid filter 11 in the disposable sterilizing filtration system. A silicone tube 19 is placed inside the peristaltic pump 4. One end of the silicone tube is connected to the siphon head of the wetting fluid container 6 and the other end is connected to the liquid inlet end of the first liquid filter 13.

[0074] The integrity tester 5 of this embodiment is connected to the air inlet end of the first gas filter 12 to perform a pressure leakage test on the disposable sterilization system and an integrity test on the liquid main filter 11 and feedback the test results;

[0075] In this embodiment, the wetting fluid container 6 is a 10L screw-on bottle. The long silicone tube on the siphon head is connected to the liquid inlet end of the first liquid filter 13 via the silicone pipeline 19, and the short silicone tube on the siphon head of the wetting fluid container 6 is connected to the liquid outlet end of the second liquid filter 15 via the silicone pipeline 19. The silicone air pipe on the siphon head of the wetting fluid container 6 is externally connected to a disc-shaped air filter.

[0076] Example 2: Conducting a post-sterilization integrity test on the liquid main filter 11 in the disposable sterilizing filtration system used in the sterilizing filtration process of preparing the semi-finished product of IPV before use:

[0077] 1. In this embodiment, the filter integrity test device of Example 1 is assembled and installed under a Class C clean environment, and the air inlet of the integrity detector 5 is connected to compressed air;

[0078] 2. Perform a pressure leak test on the disposable sterilizing filtration system in the filter integrity test device assembled in step 1. Specifically, clamp the pipes at point 7 on the disposable sterilizing filtration system with PVPP flow control valves. Turn on the compressed air and integrity tester 5. Set the test program with a test pressure of 1200 mbar and a test time of 600 s. The test result is considered passed when the measured flow rate is ≤1.60 mL / min, and the test starts automatically. The integrity tester 5 records the test process and issues the test results.

[0079] 3. If the pressure leakage test result issued by the integrity detector 5 in step 2 is passed, it indicates that the disposable sterilizing filtration system is intact and leak-free. The liquid main filter 11 in the disposable sterilizing filtration system can be subjected to a pre-use and post-sterilization integrity test. In this embodiment, the wetting fluid for the pre-use integrity test of the liquid main filter 11 is water for injection. The specific testing process is as follows:

[0080] Open the PVPP flow control valve at point 7 on the pressure-resistant braided tube 16 connected to the first liquid filter 13 and the PVPP flow control valve at point 7 on the pressure-resistant braided tube 16 connected to the second liquid filter 15, and simultaneously close the PVPP flow control valve at point 7 on the pressure-resistant braided tube 16 connected to the first gas filter 12;

[0081] Turn on the peristaltic pump 4 to allow the wetting fluid to circulate from the wetting fluid container 6 through the silicone pipe 19, the first liquid filter 13, the pressure-resistant braided tube 16, the main liquid filter 11, the pressure-resistant braided tube 16, the second liquid filter 15, and the silicone pipe 19 back to the wetting fluid container 6;

[0082] Step 5: After the wetting process is completed, the PVPP flow control valve at position 7 on the pressure-resistant braided tube 16 connected to the first liquid filter 13 is closed, and the PVPP flow control valve at position 7 on the pressure-resistant braided tube 16 connected to the first gas filter 12 is opened. The integrity detector 5 is set to a forward flow test with a test pressure of 2760 mbar and a test time of 600 s. If the measured flow rate is ≤2.10 mL / min, the test result is considered passed, and the test starts automatically. The integrity detector 5 records the test process and issues the test results.

[0083] 4. If the forward flow test result of the liquid main filter 11 issued by the integrity detector 5 in step 3 is passed, it means that the liquid main filter 11 is intact before use, and the disposable sterilization filtration system can be used to sterilize and filter the s IPV semi-finished product.

[0084] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Reference can be made to the common and similar parts between the various embodiments. For the devices disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the description is relatively simple, and the relevant parts can be referred to the method description.

[0085] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A filter integrity testing device, characterized in that: include: A disposable sterilizing filtration system, comprising a disposable sterilizing filter assembly, a sterile connector and a liquid storage bag, wherein the disposable sterilizing filter assembly is connected to the sterile connector and the liquid storage bag in sequence; A peristaltic pump, the peristaltic pump being in communication with the disposable sterilizing and filtering system; an integrity detector, the integrity detector being in communication with the disposable sterilizing and filtering system; A wetting fluid container is connected to the disposable sterilizing filtration system.

2. A filter integrity testing device according to claim 1, characterized in that: The disposable sterilizing filter assembly comprises a main liquid filter, a first gas filter, a first liquid filter, a second gas filter and a second liquid filter, wherein: The liquid inlet front end of the liquid main filter is connected to the sterile connector through a pressure-resistant braided tube, the liquid outlet rear end of the liquid main filter is connected to another sterile connector through a pressure-resistant braided tube, and the exhaust port near the liquid outlet end of the liquid main filter is connected to the liquid storage bag; The first gas filter is connected to the pressure-resistant braided tube between the liquid inlet front end of the liquid main filter and the sterile connector through a pressure-resistant braided tube and a T-shaped connector; The first liquid filter is connected to the pressure-resistant braided tube between the liquid inlet front end of the liquid main filter and the sterile connector through a pressure-resistant braided tube and a T-shaped connector, and the peristaltic pump is connected to an end of the first liquid filter away from the pressure-resistant braided tube; The second gas filter is connected to the pressure-resistant braided tube between the liquid outlet rear end of the liquid main filter and the sterile connector through a pressure-resistant braided tube and a cross connector; The second liquid filter is connected to the other end of the cross-shaped connector connected to the second gas filter, and the exhaust port of the second liquid filter is connected to the liquid storage bag.

3. A filter integrity testing device according to claim 2, characterized in that: One end of the first liquid filter away from the pressure-resistant braided tube is connected to the wetting fluid container via a silicone tube, and the silicone tube connecting the wetting fluid container and the first liquid filter is placed in the peristaltic pump; The air outlet of the integrity detector is connected to the air inlet of the first gas filter, and the integrity detector is connected to compressed gas; The wetting fluid container is connected to the liquid outlet end of the second liquid filter through a silicone pipe.

4. A filter integrity testing device according to claim 3, characterized in that: An upper point is arranged on the pressure-resistant braided tube connected to the main liquid filter, the first gas filter, the first liquid filter, the second gas filter and the second liquid filter, and a PVPP flow regulating valve is arranged at the upper point.

5. A filter integrity testing process, according to the filter integrity testing device of claim 4, characterized in that: The following steps are involved: Step 1: Perform a pressure leakage test on the disposable sterilizing filtration system before use to determine whether the disposable sterilizing filtration system is complete, connect the disposable sterilizing filter assembly, the sterile connector and the liquid storage bag, clamp the pipelines at the upper point of the disposable sterilizing filtration system with PVPP flow regulating valves, and open the PVPP flow regulating valve at the upper point of the pressure-resistant braided tube connected to the first gas filter; Step 2: Turn on the compressed gas and integrity detector, set up the test program, start automatic operation, and let the integrity detector record the test process and issue the test results; Step 3: Perform an integrity test on the liquid main filter that has passed the leakage test before use and after sterilization. After the leakage test is passed, open the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the first liquid filter and the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the second liquid filter, and close the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the first gas filter at the same time; Step 4: Turn on the peristaltic pump to allow the wetting fluid to circulate from the wetting fluid container through the silicone pipe, the first liquid filter, the pressure-resistant braided tube, the main liquid filter, the pressure-resistant braided tube, the second liquid filter, and the silicone pipe back to the wetting fluid container; Step 5: After the wetting process is completed, the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the first liquid filter is closed, and the PVPP flow control valve at the upper position of the pressure-resistant braided tube connected to the first gas filter is opened at the same time, and the test program is set on the integrity detector, and the automatic operation is started, and the integrity detector records the test process and issues the test results; Step 6: The disposable sterilization filtration system that has been sterilized before use and then tested for integrity can be used for subsequent sterilization filtration of drug solutions.

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